CDSCO License for Wireless air-conduction hearing aid

Comprehensive Guide to CDSCO Licensing for Wireless Air-Conduction Hearing Aids (Class B)

Wireless air-conduction hearing aids are critical medical devices designed to compensate for impaired hearing by incorporating advanced wireless technology. Classified under Class B (low-moderate risk) by CDSCO, these devices fall within the ENT category and require adherence to specific regulatory frameworks to ensure safety, efficacy, and quality before entering the Indian market.

With over 25 years of experience guiding 500+ companies through CDSCO licensing, we provide you with a detailed, actionable roadmap to successfully obtain your manufacturing or import license for this device.

CDSCO Regulatory Framework for Wireless Air-Conduction Hearing Aids

The Central Drugs Standard Control Organization (CDSCO) governs the regulation, manufacture, and import of medical devices in India. As per the notification 29/Misc/03/2020-DC(196), dated 06.08.2021, wireless air-conduction hearing aids are classified as Class B devices. This classification mandates compliance with the Medical Device Rules, 2017, including obtaining a manufacturing license (MD5) or import license (MD15) before distribution.

Compliance ensures that devices meet essential principles of safety and performance, including risk management, quality systems, and testing.

Risk Classification and License Requirements

The wireless air-conduction hearing aid falls under Class B (low-moderate risk). This means:

• Manufacturing License: MD5 License (Form MD3) issued by the State Licensing Authority.
• Import License: MD15 License (Form MD14) issued by the Central Licensing Authority.

Class B devices require a test license (MD13) prior to manufacturing license application, product testing at government-approved labs, and audit by a notified body.

For details on medical device classification, consult our Medical Device Classification guide.

Manufacturing License Process (MD5) for Wireless Air-Conduction Hearing Aids

The manufacturing license process for Class B medical devices involves several key stages:

1. Obtain Test License (Form MD13): This initial license permits manufacturing for testing purposes. It typically takes 1.5 to 2 months to be granted.

2. Product Testing: Conduct mandatory testing at government-recognized laboratories. Refer to the list of testing laboratories for approved facilities.

3. Prepare Documentation: Compile comprehensive technical files, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and product-specific documents.

4. Apply for MD5 License (Form MD3): Submit your complete application via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an on-site audit to verify compliance. You can check the list of notified bodies for eligible auditors.

6. Resolve Queries: Address any observations or queries raised by CDSCO or the notified body promptly.

7. Grant of License: Upon successful evaluation, the State Licensing Authority issues the MD5 manufacturing license.

The entire process typically spans 3 to 4 months, inclusive of testing, audit, and query resolution.

For a detailed walkthrough, our MD5 License Guide provides practical insights.

Manufacturing License Documents Required

Preparing a robust and complete dossier is crucial. For wireless air-conduction hearing aids (Class B), the following documents are mandatory:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications, design, and manufacturing process (Guide to Device Master Files)
• Plant Master File (PMF) covering infrastructure, equipment, and quality systems (Plant Master File Guide)
• Essential Principles Compliance Checklist
• Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management Guide)
• Test Reports from government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certification

Ensuring accuracy and completeness reduces back-and-forth with CDSCO and accelerates approval.

Import License Process (MD15) for Wireless Air-Conduction Hearing Aids

If you plan to import wireless air-conduction hearing aids into India, the following process applies:

1. Document Preparation: Assemble all required documentation prior to application.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Respond promptly to any department queries.

4. Grant of License: The Central Licensing Authority issues the MD15 import license.

The import license process typically takes 5 to 6 months.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate indicating market approval in the exporting country
• ISO 13485:2016 Certification
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Registration

Refer to our Import License Guide for detailed document checklists and process tips.

Timeline and Processing Duration

Timelines may vary based on completeness of submission and responsiveness.

Government Fees and Costs

For a Class B wireless air-conduction hearing aid, fees are as follows:

• MD5 Manufacturing License:

  • Application Fee: ₹5,000
  • Per Product Fee: ₹500

• MD13 Test License:

  • Application Fee: ₹5,000 (approx.)

• MD15 Import License:

  • Site Fee: $2,000 (approx. ₹1,50,000)
  • Per Product Fee: $1,000 (approx. ₹75,000)

Additional costs include notified body audit fees, testing laboratory charges, and professional consultancy if engaged.

Common Challenges and Solutions

Challenge: Delays in Document Preparation

Solution: Begin compiling technical files early. Utilize templates and expert consultation to ensure completeness.

Challenge: Product Testing Failures or Delays

Solution: Select accredited laboratories from the CDSCO-approved list and conduct pre-testing to identify issues early.

Challenge: Audit Non-Compliance

Solution: Conduct internal audits and gap analyses before notified body visits. Maintain robust QMS and training.

Challenge: Query Resolution Delays

Solution: Assign a dedicated regulatory point of contact to respond promptly and accurately to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing landscape can be complex. Our team, with 25+ years of regulatory expertise and over 500 successful client applications, offers tailored support including:

• Gap analysis and compliance readiness
• Document preparation and review
• Coordinating product testing and audits
• End-to-end application management

Partnering with regulatory experts accelerates approvals and mitigates risks.

Getting Started with Your CDSCO License Application for Wireless Air-Conduction Hearing Aids

To initiate your CDSCO licensing journey:

1. Assess Risk Classification: Confirm your device as Class B and understand applicable requirements.

2. Apply for Test License (MD13): Submit your application via the CDSCO MD Online Portal.

3. Prepare Technical Documentation: Leverage our Device Master File and Plant Master File guides to ensure quality.

4. Arrange Product Testing: Select an accredited testing laboratory early.

5. Plan for Notified Body Audit: Schedule the audit in advance and prepare your site accordingly.

6. Submit Manufacturing License Application (MD5): Once testing and audit are complete, apply through the online portal.

7. Monitor Application Status: Track progress and respond swiftly to any queries.

By following these steps and leveraging expert advice, your wireless air-conduction hearing aid can achieve timely CDSCO licensing, enabling successful entry into the Indian market.

For personalized assistance and to streamline your licensing process, contact us today and benefit from our extensive experience in medical device regulatory affairs.